IBUPROFENE 400MG MYLAN Viatris BOX 12 TABLETS

1. WHAT IS IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet AND WHAT IS IT USED FOR?

Pharmacotherapeutic class - ATC code: M01AE01/N02B

OTHER ANALGESICS AND ANTIPYRETICS.

This medication contains a non-steroidal anti-inflammatory drug (NSAID): ibuprofen.

It is indicated for adults and children weighing 30 kg or more (approximately 11-12 years of age), for the short-term treatment of fever and/or pain such as headaches, flu, dental pain, aches and pains and painful periods.

It is indicated in adults, after at least one medical opinion, in the treatment of mild to moderate migraine attacks, with or without aura.

2. WHAT YOU SHOULD KNOW BEFORE TAKING IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet

Never take IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet:

-after5 months of pregnancy (24 weeks of amenorrhea),

-ifyou have a history of allergy or asthma triggered by this drug or a related drug, especially other NSAIDs, acetylsalicylic acid (aspirin),

-ifyouhave a history of allergy to other components of the tablet,

-ifyouhave a history of gastrointestinal bleeding or ulcers related to previous NSAID treatments,

-youhave an ulcer or bleeding in the stomach or intestine that is evolving or recurring,

-ifyou have ongoing gastrointestinal bleeding, brain bleeding or other bleeding

-ifyou have severe liver disease,

-ifyou have severe kidney disease,

-ifyou have severe heart disease,

-ifyou suffer from systemic lupus erythematosus,

IN CASE OF DOUBT, IT IS ESSENTIAL TO ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

Warnings and precautions

Talk to your doctor or pharmacist before takingIBUPROFENEMYLAN CONSEIL 400 mg, film-coated tablet.

At high doses, above 1200 mg/day, this medicine has anti-inflammatory properties and can cause sometimes serious inconveniences which are those observed with non-steroidal anti-inflammatory drugs.

Anti-inflammatory/antalgic drugs such as ibuprofen may be associated with a slightly increased risk of heart attack or stroke, especially when used in high doses. Do not exceed the recommended dose or duration of treatment.

Discuss your treatment your doctor or pharmacist before taking IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet if you:

-haveheart problems including heart failure, angina (chest pain) or if you have had a heart attack, bypass surgery, peripheral arterial disease (poor circulation in the legs or feet due to narrowed or blocked arteries) or any kind of stroke (including "mini-strokes" or transient ischemic attacks (TIAs).

-havehigh blood pressure, diabetes, high cholesterol, a family history of heart disease or stroke, or are a smoker.

The diagnosis and follow-up of migraine attacks in children require medical advice.

Special warnings

If you are a woman, IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet may affect your fertility. It is not recommended for use in women who wish to conceive a child. In women who have difficulty conceiving or who are undergoing reproductive testing, please talk to your doctor or pharmacist before taking IBUPROFENE MYLAN CONSEIL 400 mg film-coated tablets.

Elderly subjects have a higher risk of adverse reactions, especially gastrointestinal bleeding, ulcers and perforations. Renal, hepatic and cardiac functions should be closely monitored. Dosage should be kept as low as possible for the shortest time necessary to relieve symptoms.

In dehydrated children and adolescents, there is a risk of renal failure.

BEFORE USING THIS MEDICATION, CONSULT YOUR PHYSICIAN IF YOU HAVE:

-ahistory of asthma associated with chronic rhinitis, chronic sinusitis or polyps in the nose. The administration of this speciality may lead to an asthma attack, particularly in certain subjects who are allergic to acetylsalicylic acid (aspirin) or to non-steroidal anti-inflammatory drugs (see section "Never take IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet in the following cases"),

-coagulation disorders, taking an anticoagulant treatment. This drug may cause serious gastrointestinal manifestations,

-digestive history(hiatal hernia, digestive hemorrhage, stomach or duodenum ulcer),

-heart, liver or kidneydisease

-chicken pox.This medication is not recommended because of exceptional serious skin infections,

-concomitant treatmentwithother drugs that increase the risk of peptic ulcer or bleeding, for example oral corticosteroids, antidepressants (those of the SSRI type, i.e. Selective Serotonin Reuptake Inhibitors), drugs that prevent the formation of blood clots such as aspirin or anticoagulants such as warfarin. If you have any of these conditions, talk to your doctor before taking IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet (see "Taking or using other medicines"),

-concomitant treatmentwithmethotrexate at doses higher than 20 mg per week or with pemetrexed (see section "Taking or using other medicines").

DURING TREATMENT, IN CASE OF:

-visual disturbances,PREVENT YOUR DOCTOR,

-gastrointestinal haemorrhage (discharge of blood through the mouth or in the stools, black stools), STOP THE TREATMENT AND CONTACT A DOCTOR OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,

-signson the skin or mucous membranes that resemble a burn (redness with bullae or blisters, ulcerations), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY,

-signssuggestive of allergy to this drug, including asthma attack or sudden swelling of the face and neck (see "What are the possible side effects?"), STOP THE TREATMENT AND CONTACT A PHYSICIAN OR EMERGENCY MEDICAL SERVICE IMMEDIATELY.

Other medicines and IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet

TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING, HAVE RECENTLY TAKEN OR MAY TAKE ANY OTHER MEDICINE, EVEN IF IT IS OBTAINED WITHOUT A PRESCRIPTION.

SOME MEDICINES CANNOT BE USED AT THE SAME TIME, WHILE OTHER MEDICINES REQUIRE SPECIFIC CHANGES (E.G. IN DOSE).

IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet may change the action of some other medicines or the effect of IBUPROFENE MYLAN CONSEIL may affect or be affected by some other medicines. For example:

-anti-coagulantdrugs (i.e., those that thin the blood/prevent clots such as aspirin/acetylsalicylic acid, warfarin, ticlopidine),

-Drugsthatreduce high blood pressure (ACE inhibitors such as captopril, beta-blockers such as atenolol, angiotensin II receptor blockers such as losartan)

-aspirin(acetylsalicylic acid) or other non-steroidal anti-inflammatory drugs

-corticosteroids,

-lithium,

-methotrexate,

-certainantidepressants (selective serotonin reuptake inhibitors)

-premethrexed

-ciclosporin, tacrolimus.

Some other drugs may also affect or be affected by treatment with IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet. Therefore, you should always ask your doctor or pharmacist for advice before using IBUPROFENE MYLAN CONSEIL 400 mg film-coated tablets with other medicines.

IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet with food, drink and alcohol

Not applicable.

Pregnancy and breastfeeding

IF YOU ARE PREGNANT OR BREASTFEEDING, THINK YOU MIGHT BE PREGNANT OR ARE PLANNING TO BECOME PREGNANT, ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE BEFORE TAKING THIS MEDICINE.

Pregnancy

During the first trimester of pregnancy (12 weeks of amenorrhea, i.e. 12 weeks after the^first day of your last menstrual period), your doctor may need to prescribe this medication.

From 2.5 to 5 months of pregnancy (12 to 24 weeks of amenorrhea), this medication should only be used on the advice of your doctor and taken for short periods. Prolonged use of this medication is strongly discouraged.

After 5 months of pregnancy (after 24 weeks of amenorrhea), you must NOT take this medication, because its effects on your child can have serious consequences, especially on the cardiopulmonary and renal levels, even with a single dose.

If you have taken this medicine when you were pregnant for more than five months, please talk to your obstetrician gynecologist so that an appropriate monitoring can be proposed.

Breastfeeding

This medication passes into breast milk. As a precautionary measure, it should not be used during breastfeeding.

Sportsmen

Not applicable.

Driving and using machines

In rare cases, dizziness and blurred vision may occur with this medication.

IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet contains :

Not applicable.

3. HOW TO TAKE IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet

The occurrence of adverse effects can be minimized by using the lowest possible dose for the shortest time necessary to relieve symptoms.

Method of administration

Oral use.

Swallow the tablet without chewing, with a large glass of water.

The tablets should preferably be taken with a meal.

Dosage

Painful and/or febrile conditions

RESERVED FOR ADULTS AND CHILDREN FROM 30 kg (about 11-12 years).

The usual dosage is 1 tablet (400 mg) per dose, to be repeated if necessary after 6 hours. In all cases, do not exceed 3 tablets per day (1200 mg per day).

The 400 mg tablet is reserved for pain or fever that is more intense or not relieved by a 200 mg ibuprofen tablet.

Regular doses help avoid fever or pain peaks. They should be taken at least 6 hours apart.

Elderly patients are at increased risk of adverse effects, so use the lowest possible dose for the shortest time needed to relieve symptoms.

Do not exceed recommended doses or duration of treatment (3 days for fever, 5 days for pain).

The maximum dosage is 3 tablets per day (1200 mg).

In case of migraine attack

RESERVED FOR ADULTS.

1 tablet at 400 mg as soon as possible after the onset of the attack.

If a patient is not relieved after the first dose, a second dose should not be taken during the same attack. However, the attack can be treated with another non-steroidal anti-inflammatory drug or aspirin.

If the pain recurs, a second dose may be taken provided that an interval of 8 hours is observed between the 2 doses.

If in doubt, ask your doctor or pharmacist for advice.

Duration of treatment

If the pain persists more than 5 days or the fever more than 3 days, if they worsen or in the event of appearance of a new disorder, inform your doctor.

In case of migraine attack, the duration of treatment should not exceed 3 days.

If the symptoms persist, worsen or if new symptoms appear, ask your pharmacist or doctor for advice.

If you feel that the effect of IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet, is too strong or too weak: consult your doctor or pharmacist.

If you have taken more IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet than you should have, contact your doctor or pharmacist immediately:

Talk to your doctor or pharmacist immediately.

In case of accidental overdose, or intoxication, STOP THE TREATMENT AND SEEK MEDICAL ATTENTION QUICKLY.

If you forget to take IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet :

Do not take a double dose to make up for the one you forgot to take.

If you stop taking IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet :

Not applicable.

4. WHAT ARE THE POSSIBLE SIDE EFFECTS?

Like all medicines, this medicine can cause side effects, but they do not always occur in everyone.

Drugs such as IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet may increase the risk of heart attack (myocardial infarction) or stroke.

Allergic reactions may occur:

-cutaneous: rash on the skin, itching, edema, aggravation of chronic urticaria,

-Respiratory: asthma attack type,

-general: sudden swelling of the face and neck (angioedema).

In some rare cases, gastrointestinal bleeding may occur (see "Special precautions with IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet"). The higher the dosage used, the more frequent it is.

In exceptional cases, headaches accompanied by nausea, vomiting and stiffness of the neck may be observed.

Very exceptionally, bullous manifestations of the skin or mucous membranes may occur (burning sensation accompanied by redness with bullae, blisters, ulcerations).

Exceptionally, serious skin infections have been observed in cases of chickenpox.

In all cases, treatment must be stopped immediately and your doctor must be notified.

During the treatment, it is possible that occur:

-digestivedisorders: stomach ache, vomiting, nausea, diarrhea, constipation,

-exceptionally, dizziness, headaches, rare visual disturbances, significant decrease in urine output, renal insufficiency.

In all these cases, you must inform your doctor.

Exceptionally, changes in the liver balance or blood count (decrease in white or red blood cells) have been observed and may be serious.

Reporting side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this leaflet. You can also report adverse reactions directly through the national reporting system: Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the network of Regional Pharmacovigilance Centres

By reporting adverse reactions, you contribute to providing more information on the safety of the drug.

5. HOW TO USE IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date indicated on the box.

The expiration date refers to the last day of that month.

This medication does not require special storage precautions.

Do not dispose of any medication down the drain or with your regular garbage. Ask your pharmacist to dispose of any medication you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What IBUPROFENE MYLAN CONSEIL 400 mg film-coated tablet contains

-The active substance is :

Ibuprofen........................................................................................................................ 400.00 mg

As ibuprofen lysinate .................................................................................... 684.00 mg

For one film-coated tablet.

-Other components are:

Core: microcrystalline cellulose, colloidal anhydrous silica, crospovidone type A, crospovidone type B, povidone K30, magnesium stearate, talc.

Film coating: OPADRY II white 85F18422 [hydrolyzed polyvinyl alcohol, titanium dioxide (E171), macrogol 3350, talc].

Printing ink: OPACODE black S-1-17823 (shellac, isopropyl alcohol, black iron oxide (E172), chlorobutanol anhydrous, propylene glycol, ammonium hydroxide).

What IBUPROFENE MYLAN CONSEIL 400 mg, film-coated tablet is and what it contains

This medicine is a white to off-white, oval, biconvex, film-coated tablet with bevelled edges, engraved with "M" and IL2" in black ink on one side.

Boxes of 10, 12 or 15 tablets.

All presentations may not be marketed.

Marketing Authorization Holder

MYLAN S.A.S

117 ALLEE DES PARCS

69800 SAINT-PRIEST